Today, FDA issued a Federal Register notice (here) announcing the release of 24 new product specific guidances (PSGs) and 20 revised guidances. These guidances provide the FDA’s current thinking on the methods to establish bioequivalence for specific products.
The new and revised guidances can be found on the FDA webpage here. Please note that, as of this morning, some of the links to the guidances have not gone active as of 6:40AM PST. Check back tomorrow for those guidances that cannot be accessed today.
